Individual Irritable Bowel Syndrome Symptoms Research Articles

Efficacy of a low FODMAP diet in irritable bowel syndrome: systematic review and network meta-analysis

ObjectiveA diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) is recommended for irritable bowel syndrome (IBS), if general lifestyle and dietary advice fails. However, although the impact of...

Current US Food and Drug Administration-Approved Pharmacologic Therapies for the Treatment of Irritable Bowel Syndrome with Diarrhea.

Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by abdominal pain and alterations in stool form and/or frequency, leading to reduced quality of life. Pharmacologic agents currently approved by the US Food and Drug Administration for treatment of IBS with diarrhea (IBS-D) in adults are the nonsystemic antibiotic rifaximin, the mixed µ- and κ-opioid receptor agonist/δ-opioid antagonist eluxadoline, and the selective serotonin 5-HT3 antagonist alosetron (the last of which is indicated only in women with severe IBS-D refractory to conventional therapy). Both eluxadoline and alosetron are administered as chronic daily therapies; rifaximin is given as a 2-week course of treatment with repeat courses administered as needed for symptom recurrence. Presumed mechanisms of action of rifaximin include modulation of the gut microbiota, anti-inflammatory activity, normalization of visceral hypersensitivity, and reduction in intestinal permeability. Eluxadoline targets opioid receptors in the gastrointestinal (GI) tract, resulting in decreased GI motility, fluid secretion, and visceral pain perception. Alosetron antagonizes serotonergic afferent neural signals and also slows GI motility. The efficacy and safety of these agents have been investigated in several rigorous clinical trials, and it has been demonstrated that they improve global and individual IBS symptoms. This review highlights the pivotal efficacy and safety data of the three pharmacologic agents currently indicated in the USA for the management of IBS-D in adults.Funding: Salix Pharmaceuticals.

Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea

BackgroundGlobal assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms” in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D).MethodsThe same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks after a one-week baseline period. To explore and examine endpoints that allow evaluation of “clinically meaningful improvements focusing on the patient’s chief complaint,” the chief complaint and its relief by this study drug were assessed in this exploratory study.ResultsRates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point, P = 0.027) throughout the treatment period, except at week 6.ConclusionsRamosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).

Effects of probiotic type, dose and treatment duration on irritable bowel syndrome diagnosed by Rome III criteria: a meta-analysis.

BackgroundIrritable bowel syndrome (IBS) is one of the most common functional gastroenterological diseases, affecting 11.2 % of people worldwide. Previous studies have shown that probiotic treatment may benefit IBS patients. However, the effect of probiotics and the appropriate type, dose, and treatment duration for IBS are still unclear. The aim of the current study was to assess the efficacy of different probiotic types, doses and treatment durations in IBS patients diagnosed by Rome III criteria via a meta-analysis of randomized controlled trials (RCTs).MethodsMedline, EMBASE, and the Cochrane Central Register of Controlled Trials up to October 2015 were searched. RCTs including comparisons between the effects of probiotics and placebo on IBS patients diagnosed by Rome III criteria were eligible. Dichotomous data were pooled to obtain the relative risk (RR) with a 95 % confidence interval (CI), whereas continuous data were pooled using a standardized mean difference (SMD) with a 95 % CI.ResultsTwenty-one RCTs were included in this meta-analysis. Probiotic therapy was associated with more improvement than placebo administration in overall symptom response (RR: 1.82, 95 % CI 1.27 to 2.60) and quality of life (QoL) (SMD: 0.29, 95 % CI 0.08 to 0.50), but not in individual IBS symptoms. Single probiotics, a low dose, and a short treatment duration were more effective with respect to overall symptom response and QoL. No differences were detected in individual IBS symptoms in the subgroup analyses.ConclusionProbiotics are an effective pharmacological therapy in IBS patients. Single probiotics at a low dose and with a short treatment duration appear to be more effective in improving overall symptom response and QoL, but more evidence for these effects is still needed.Electronic supplementary materialThe online version of this article (doi:10.1186/s12876-016-0470-z) contains supplementary material, which is available to authorized users.

Distinct microbial populations exist in the mucosa‐associated microbiota of sub‐groups of irritable bowel syndrome

There is increasing evidence to support a role for the gastrointestinal microbiota in the etiology of irritable bowel syndrome (IBS). Given the evidence of an inflammatory component to IBS, the mucosa-associated microbiota potentially play a key role in its pathogenesis. The objectives were to compare the mucosa-associated microbiota between patients with diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C) and controls using fluorescent in situ hybridization and to correlate specific bacteria groups with individual IBS symptoms. Forty-seven patients with IBS (27 IBS-D and 20 IBS-C) and 26 healthy controls were recruited to the study. Snap-frozen rectal biopsies were taken at colonoscopy and bacterial quantification performed by hybridizing frozen sections with bacterial-group specific oligonucleotide probes. Patients with IBS had significantly greater numbers of total mucosa-associated bacteria per mm of rectal epithelium than controls [median 218 (IQR - 209) vs 128 (121) P = 0.007], and this was chiefly comprised of bacteroides IBS [69 (67) vs 14 (41) P = 0.001] and Eubacterium rectale-Clostridium coccoides [52 (58) vs 25 (35) P = 0.03]. Analysis of IBS sub-groups demonstrated that bifidobacteria were lower in the IBS-D group than in the IBS-C group and controls [24 (32) vs 54 (88) vs 32 (35) P = 0.011]. Finally, amongst patients with IBS, the maximum number of stools per day negatively correlated with the number of mucosa-associated bifidobacteria (P < 0.001) and lactobacilli (P = 0.002). The mucosa-associated microbiota in patients with IBS is significantly different from healthy controls with increases in bacteroides and clostridia and a reduction in bifidobacteria in patients with IBS-D.

S1314 The Effect of Probiotic Mixture on the Symptoms and Fecal Microbiota in Diarrhea-Dominant Irritable Bowel Syndrome: Randomized, Double-Blind, Placebo-Controlled Trial

Background & Aims: Some reports suggest that probiotics are helpful for treatment of Irritable bowel syndrome (IBS). The aim of this study was to evaluate the effects of probiotic mixture compared with placebo on the symptoms and the compositions of fecal microbiota in patients with diarrhea-dominant IBS (D-IBS). Methods: Forty-seven patients with D-IBS consented by ROME III were randomized in a parallel group, double-blind design to placebo or seven probiotics mixture 7x1011 CFU (Streptococcus thermophous, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breve) daily for 8 weeks after 1-week run-in period. The primary outcome was the adequate relief (AR) for overall IBS symptoms; secondary outcomes included the individual IBS symptoms, and the IBS quality of life (IBS-QOL). The AR was weekly checked by questionnaire for 10 weeks (8 weeks of treatment phase, 2 weeks of post-treatment phase). The IBS symptom diary based on visual analogue scale (VAS for abdominal pain, abdominal discomfort, diarrhea, urgency, mucus in stool, bloating, passage of gas) and stool parameters (hardness and frequency) were recorded on a daily basis and assessed each week for 11 weeks. IBS-QOL assessment and stool sampling for evaluating the composition of fecal microbiota by denaturing gradient gel electrophoresis (DGGE) were performed at the beginning and at the end of the treatment phase. Results: For all weeks, the proportions of AR was higher in probiotics group than placebo (p<0.05). The proportion of the patients who reported “yes” to adequate relief on half of the weeks (5 weeks) in the treatment trial was significantly higher in probiotics group than placebo (50% vs. 13%, p= 0.01). However, the improvements of the individual symptom scores and stool parameters were not superior in probiotics group. In IBS-QOL, the changing rates of overall scores for probiotics group tended to be higher than those for placebo (21.3±21.6% vs. 9.0±21.5%, p=0.073). The improvements of all 8 domains of IBS-QOL were consistently superior in probiotics group. In the comparison for DGGE profiles of fecal bacteria, there was no difference in the similarities of their bacterial compositions between the two groups. The concordance rates of bacterial compositions from the two time-points were 66.2±13.4% in probiotics and 69.1±11.8% in placebo group (p=0.519). Conclusion: The probiotic mixture is effective in providing adequate relief of overall IBS symptoms, and has a tendency to improve of IBS-QOL in D-IBS. But, the effect of probiotics is not related with the compositional changes of fecal microbiota.

S1316 Patient Willingness to use ROSE-010: A Subcutaneous (SC) GLP-1 Analogue for IBS Pain Episodes

Background & Aims: Some reports suggest that probiotics are helpful for treatment of Irritable bowel syndrome (IBS). The aim of this study was to evaluate the effects of probiotic mixture compared with placebo on the symptoms and the compositions of fecal microbiota in patients with diarrhea-dominant IBS (D-IBS). Methods: Forty-seven patients with D-IBS consented by ROME III were randomized in a parallel group, double-blind design to placebo or seven probiotics mixture 7x1011 CFU (Streptococcus thermophous, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breve) daily for 8 weeks after 1-week run-in period. The primary outcome was the adequate relief (AR) for overall IBS symptoms; secondary outcomes included the individual IBS symptoms, and the IBS quality of life (IBS-QOL). The AR was weekly checked by questionnaire for 10 weeks (8 weeks of treatment phase, 2 weeks of post-treatment phase). The IBS symptom diary based on visual analogue scale (VAS for abdominal pain, abdominal discomfort, diarrhea, urgency, mucus in stool, bloating, passage of gas) and stool parameters (hardness and frequency) were recorded on a daily basis and assessed each week for 11 weeks. IBS-QOL assessment and stool sampling for evaluating the composition of fecal microbiota by denaturing gradient gel electrophoresis (DGGE) were performed at the beginning and at the end of the treatment phase. Results: For all weeks, the proportions of AR was higher in probiotics group than placebo (p<0.05). The proportion of the patients who reported “yes” to adequate relief on half of the weeks (5 weeks) in the treatment trial was significantly higher in probiotics group than placebo (50% vs. 13%, p= 0.01). However, the improvements of the individual symptom scores and stool parameters were not superior in probiotics group. In IBS-QOL, the changing rates of overall scores for probiotics group tended to be higher than those for placebo (21.3±21.6% vs. 9.0±21.5%, p=0.073). The improvements of all 8 domains of IBS-QOL were consistently superior in probiotics group. In the comparison for DGGE profiles of fecal bacteria, there was no difference in the similarities of their bacterial compositions between the two groups. The concordance rates of bacterial compositions from the two time-points were 66.2±13.4% in probiotics and 69.1±11.8% in placebo group (p=0.519). Conclusion: The probiotic mixture is effective in providing adequate relief of overall IBS symptoms, and has a tendency to improve of IBS-QOL in D-IBS. But, the effect of probiotics is not related with the compositional changes of fecal microbiota.

S1315 Identification of Novel Metabolites in Serum of Patients With Irritable Bowel Syndrome

Background & Aims: Some reports suggest that probiotics are helpful for treatment of Irritable bowel syndrome (IBS). The aim of this study was to evaluate the effects of probiotic mixture compared with placebo on the symptoms and the compositions of fecal microbiota in patients with diarrhea-dominant IBS (D-IBS). Methods: Forty-seven patients with D-IBS consented by ROME III were randomized in a parallel group, double-blind design to placebo or seven probiotics mixture 7x1011 CFU (Streptococcus thermophous, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breve) daily for 8 weeks after 1-week run-in period. The primary outcome was the adequate relief (AR) for overall IBS symptoms; secondary outcomes included the individual IBS symptoms, and the IBS quality of life (IBS-QOL). The AR was weekly checked by questionnaire for 10 weeks (8 weeks of treatment phase, 2 weeks of post-treatment phase). The IBS symptom diary based on visual analogue scale (VAS for abdominal pain, abdominal discomfort, diarrhea, urgency, mucus in stool, bloating, passage of gas) and stool parameters (hardness and frequency) were recorded on a daily basis and assessed each week for 11 weeks. IBS-QOL assessment and stool sampling for evaluating the composition of fecal microbiota by denaturing gradient gel electrophoresis (DGGE) were performed at the beginning and at the end of the treatment phase. Results: For all weeks, the proportions of AR was higher in probiotics group than placebo (p<0.05). The proportion of the patients who reported “yes” to adequate relief on half of the weeks (5 weeks) in the treatment trial was significantly higher in probiotics group than placebo (50% vs. 13%, p= 0.01). However, the improvements of the individual symptom scores and stool parameters were not superior in probiotics group. In IBS-QOL, the changing rates of overall scores for probiotics group tended to be higher than those for placebo (21.3±21.6% vs. 9.0±21.5%, p=0.073). The improvements of all 8 domains of IBS-QOL were consistently superior in probiotics group. In the comparison for DGGE profiles of fecal bacteria, there was no difference in the similarities of their bacterial compositions between the two groups. The concordance rates of bacterial compositions from the two time-points were 66.2±13.4% in probiotics and 69.1±11.8% in placebo group (p=0.519). Conclusion: The probiotic mixture is effective in providing adequate relief of overall IBS symptoms, and has a tendency to improve of IBS-QOL in D-IBS. But, the effect of probiotics is not related with the compositional changes of fecal microbiota.

Prebiotics for irritable bowel syndrome

Evaluation of: Silk DBA, Davis A, Vulevic J, Tzortzis G, Gibson GR. Clinical trial: the effects of a trans-galactooligosaccharide on faecal microbiota and symptoms in irritable bowel syndrome. Aliment. Pharmacol. Ther. 29, 508–518 (2009).While a variety of probiotic preparations have been quite extensively studied in the short-term treatment of irritable bowel syndrome (IBS), little is known regarding the efficacy of prebiotics – the nondigestible but fermentable foods that promote the growth of one or a number of species of beneficial commensal flora in the human colon – in IBS. In this study, a specially designed prebiotic, a trans-galactooligosaccharide, was studied in two doses, 3.5 and 7 g, in a single-blind, randomized, placebo-controlled trial of 4-weeks duration in Rome II-positive IBS patients. The researchers found that the prebiotic altered the fecal flora, increasing the numbers of Bifidobacteria in a dose-dependent manner and also improved, but in a less predictable manner, individual IBS symptoms, such as flatulence and bloating, as well as impacting on a composite score of the subjects’ global assessment of relief and quality of life. This study indicates that prebiotics, either on their own or in combination with a probiotic, deserve further study in IBS.

What is the evidence for the use of probiotics in functional disorders?

A rationale for the use of probiotics for a number of functional gastrointestinal symptoms and syndromes can be developed, and an experimental basis for their use continues to emerge, but data from well-conducted clinical trials of probiotics in this area remain scarce. Irritable bowel syndrome (IBS) has attracted the most attention; recent revelations regarding the potential pathogenic roles of the enteric flora and immune activation have led to reawakened interest in bacterio-therapy for this common and challenging disorder. Some recent randomized, controlled studies attest to the efficacy of some probiotics in alleviating individual IBS symptoms, and selected strains have a more global impact. Evidence for long-term efficacy is also beginning to emerge, though more studies are needed in this regard. In other functional syndromes, data are far from adequate to make recommendations, but there is evidence for efficacy of probiotics in treating individual symptoms such as diarrhea, constipation, and bloating. The interpretation of much of the literature in this area is complicated by lack of quality control, use of many different species and strains, and, above all, significant deficiencies in trial methodology.

Tegaserod for Female Patients Suffering From IBS With Mixed Bowel Habits or Constipation: A Randomized Controlled Trial

Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C). This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe. Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily. The primary efficacy variable was the patient's assessment of satisfactory relief over the 4-wk treatment period. The proportion of patients reporting satisfactory relief for >/=3 of 4 treatment weeks (75% rule) and individual IBS symptoms were assessed. In total, 661 women were randomized (IBS-Mixed 324, IBS-C 337). Baseline symptom assessments identified clear differences between the two cohorts. Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk (OR 1.75, 95% CI 1.35-2.25, P < 0.001) in both IBS-Mixed and IBS-C patients. Using the 75% rule, 52.3% of tegaserod-receiving IBS-M patients and 43.3% of IBS-C patients were responders (vs 36.3, OR 1.88, 95% CI 1.16-3.04, P < 0.010; and 28.9, OR 1.90, 95% CI 1.19-3.05, P < 0.008 for placebo, respectively). The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea (1.5%) and abdominal pain (0.9%). Overall 7% of IBS-C patients reported diarrhea compared to 12% of IBS-Mixed (placebo 2.4%, 1.8%, respectively). Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C.

A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome

We randomized, at two sites, 210 patients with Rome II diagnosed irritable bowel syndrome (IBS), of at least moderate severity, to one of three conditions: group-based cognitive therapy (CT; n=120), psychoeducational support groups ( n=46) as an active control, or intensive symptom and daily stress monitoring ( n=44). One hundred eighty-eight participants completed the initial treatment. Those in symptom monitoring were then crossed over to CT. For an intent to treat analysis on a composite GI symptom measure derived from daily symptom diaries, both CT and the psychoeducational support groups were significantly more improved than those in the intensive symptom monitoring condition, but the CT and psychoeducational support group did not differ. Among treatment completers on the same composite measure of GI symptoms, again, both CT and psychoeducational support groups were statistically superior to symptom monitoring but did not differ on the symptom composite, or on any other measure. On individual IBS symptoms, both CT and psychoeducational support were statistically superior to symptom monitoring on reductions in abdominal pain and tenderness and for flatulence. Patient global ratings at the end of treatment showed the two active conditions statistically superior to symptom monitoring on change in Bowel Regularity, with CT superior to symptom monitoring on reduction in overall pain and in improvement in sense of well-being. Three-month follow-up data on 175 patients revealed maintenance of significant improvement or continued significant improvement on all IBS symptoms, including the McGill Pain Questionnaire. Group CT and psychoeducational support groups continued not to differ on any measure. We thus conclude that group CT is not superior to an attention placebo control condition.

The spectrum of irritable bowel syndrome: A clinical review

Background: Irritable bowel syndrome (IBS) is associated with a substantial burden on individual patients, health care systems, and society as a whole. Objectives: This review article provides an overview of the disease state and discusses treatment options. Methods: The MEDLINE database was searched for original research and review articles published in English (from 1966 to July 2005) using the medical subject heading irritable bowel syndrome and the following subheadings: diagnosis, economics, pathophysiology, and therapy. Preference was given to articles that focused on new insights regarding pathophysiology and to those that addressed global symptom improvement for IBS. Results: Symptoms of IBS vary with each patient anddisease episode. Although improvement in individual IBS symptoms is desirable, the overall goal in managing patients with IBS is to achieve global symptom improvement. Traditional IBS therapies (ie, psychotherapy/behavioral therapy, bulking agents, antidiarrheals, antispasmodics, and tricyclic antidepressants) have lacked demonstrable efficacy in randomized controlled trials. Recent improvements in the understanding of IBS pathophysiology, particularly regarding the role of neurotransmitters and hormones in gastrointestinal motility, secretion, and visceral perception, have resulted in the development of novel treatments for IBS. In clinical trials, IBS-specific treatments (ie, agents that affect serotonergic pathways) have been associated with significant improvements in global symptoms. However, the added cost of treatment with these agents and the potential risks of serious adverse events (eg, severe constipation, severe diarrhea, ischemic colitis) may preclude their widespread use. Initial cost-effectiveness analyses with the novel IBS-specific agents suggest the benefits may outweigh the added costs. From a managed care perspective, the costs incurred by IBS-specific therapies may be offset by subsequent reductions in health care resource utilization by patients with IBS. Conclusions: IBS-specific agents offer an opportunityfor patients with IBS to achieve global symptom improvement. However, when weighing the costs and potential risks against the potential benefits, clinicians should consider the nature and severity of the patient's symptoms, the degree of functional impairment, and the presence of psychosocial comorbidities.

Relationship between symptoms and hypersensitivity to rectal distension in patients with irritable bowel syndrome

Visceral hypersensitivity is considered an important pathophysiological mechanism in irritable bowel syndrome, yet its relationship to symptoms is unclear. To detect possible associations between symptoms and the presence of hypersensitivity to rectal distension in patients with irritable bowel syndrome. Ninety-two irritable bowel syndrome patients and 17 healthy volunteers underwent a rectal barostat study. The association between specific irritable bowel syndrome symptoms and the presence of hypersensitivity was examined using Area under the Receiver Operating Characteristic curves. Irritable bowel syndrome patients had significantly lower thresholds for discomfort/pain than healthy volunteers: 24 (18-30) and 30 (27-45) mmHg above minimal distending pressure, respectively. Forty-one patients (45%) showed hypersensitivity to rectal distension. Proportions of patients with different predominant bowel habits were similar in hypersensitive and normosensitive subgroups (diarrhoea predominant: 39 and 41%, respectively; alternating type: 27 and 28%, respectively; constipation predominant: 34 and 31%, respectively). Severe abdominal pain was more frequent in hypersensitive, compared with normosensitive patients (88% vs. 67%, P = 0.02), but none of the individual irritable bowel syndrome symptoms could accurately predict the presence of hypersensitivity, as assessed by Area under the Receiver Operating Characteristic curve analysis. Hypersensitive and normosensitive irritable bowel syndrome patients present with comparable, heterogeneous symptomatology. Therefore, selection based on clinical parameters is unlikely to discriminate individual irritable bowel syndrome patients with visceral hypersensitivity from those with normal visceral sensitivity.

A double‐blind, placebo‐controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome

Background: Tegaserod has been shown to be an effective therapy for the multiple symptoms of irritable bowel syndrome (IBS) in Western and Asia‐Pacific populations. This study evaluated the efficacy, safety and tolerability of tegaserod versus placebo in patients with IBS. Methods: Patients with IBS (excluding those whose primary bowel symptom was diarrhoea) were randomized to receive either tegaserod 6 mg b.i.d. (n = 327) or placebo (n = 320) for a 12‐week double‐blind treatment period. The primary efficacy variable (over weeks 1 to 4) was the response to the question: ‘Over the past week do you consider that you have had satisfactory relief from your IBS symptoms?’ Secondary efficacy variables assessed overall satisfactory relief over 12 weeks and the individual IBS symptoms. Results: Overall satisfactory relief was greater in the tegaserod group than in the placebo group. Over weeks 1 to 4, the odds ratio was 1.54, that is, the odds of satisfactory relief were 54% higher in the tegaserod group than in the placebo group (95% confidence interval for odds ratio (CI) (1.14, 2.08), P = 0.0049). Over weeks 1 to 12, the odds ratio was 1.78, that is, the odds of satisfactory relief were 78% higher in the tegaserod group than in the placebo group (95% CI (1.35, 2.34), P < 0.0001). A statistically significant therapeutic gain over placebo was observed for the majority of weeks from week 1 to week 12 (except weeks 1 and 4), with a mean therapeutic gain of 7.3 and 10.6 percentage points over weeks 1–4 and weeks 1–12, respectively. Headache was the most commonly reported adverse event (8.0% tegaserod versus 4.7% placebo). Diarrhoea was reported by 9.2% of patients on tegaserod (1.3% on placebo) and led to discontinuation in 2.8% of tegaserod patients. Conclusion: Tegaserod 6 mg b.i.d. is an effective, safe and well‐tolerated treatment in patients suffering from IBS without diarrhoea as primary bowel symptom.

Review: smooth muscle relaxants treat abdominal pain and loperamide reduces diarrhoea in irritable bowel syndrome

(2000) Ann Intern Med 133, 136. Jailwala J, Imperiale TF, Kroenke K. . Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials. . Jul 18;...